MISSION 1820MSKRecalls & reported problems
Bard Peripheral Vascular, Inc. · Mission Disposable Core Biopsy Instrument Kit - 18Gx20cm · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741097072), received between Oct 10, 2018 and Apr 15, 2026 — classified as 1 injury, 10 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (5 reports).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Nov 8, 2023Open, Classified
The internal diameter of the coaxial cannula may be smaller or larger than the external diameter of the biopsy needle, and the length of the cannula may exceed the stated length on the label. As a result, the biopsy needle may not fit properly into the coaxial cannula, preventing access to the target tissue, which could lead to tissue injury, longer and repeat procedures.
Z-0643-2024 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Device-Device Incompatibility5
- Break3
- Detachment of Device or Device Component3
- Failure to Fire1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- No Consequences Or Impact To Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 15, 2026Failure to Fire; Detachment of Device or Device Component
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED LIVER BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE USING A MISSION BIOPSY KIT. PRIOR TO THE PROCEDURE, THE OUTER CANNULA COULDN'T BE FIRED. THE PROCEDURE WAS COMPLETED BY ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24884821 ↗InjuryMar 5, 2026Break
ON (B)(6) 2026, A PATIENT UNDERWENT A BIOPSY PROCEDURE BY USING MISSION KIT. IT WAS REPORTED THAT DURING THE PROCEDURE THE NEEDLE ALLEGEDLY BROKE IN THE LESION. FURTHER IT WAS REPORTED THAT THE BROKEN NEEDLE REQUIRED REMOVAL IN IR. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24516415 ↗MalfunctionAug 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MISSION. PRIOR THE PROCEDURE, THE DEVICE PLASTIC TIP WAS BROKEN. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22685396 ↗MalfunctionJan 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE PLASTIC HUB OF THE INNER STYLET ALLEGEDLY FELL OFF. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21069439 ↗MalfunctionDec 15, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE COAXIAL NEEDLE IN THE KIT ALLEGEDLY WAS NOT COMPATIBLE WITH THE BIOPSY NEEDLE. IT WAS FURTHER REPORTED THAT THE INTERNAL DIAMETER OF THE COAXIAL CANNULA ALLEGEDLY MAY BE SMALLER OR LARGER THAN THE EXTERNAL DIAMETER OF THE BIOPSY NEEDLE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18333634 ↗MalfunctionDec 15, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE COAXIAL NEEDLE IN THE KIT ALLEGEDLY WAS NOT COMPATIBLE WITH THE BIOPSY NEEDLE. IT WAS FURTHER REPORTED THAT THE INTERNAL DIAMETER OF THE COAXIAL CANNULA ALLEGEDLY MAY BE SMALLER OR LARGER THAN THE EXTERNAL DIAMETER OF THE BIOPSY NEEDLE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18333633 ↗MalfunctionDec 15, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE COAXIAL NEEDLE IN THE KIT ALLEGEDLY WAS NOT COMPATIBLE WITH THE BIOPSY NEEDLE. IT WAS FURTHER REPORTED THAT THE INTERNAL DIAMETER OF THE COAXIAL CANNULA ALLEGEDLY MAY BE SMALLER OR LARGER THAN THE EXTERNAL DIAMETER OF THE BIOPSY NEEDLE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18333632 ↗MalfunctionDec 15, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE COAXIAL NEEDLE IN THE KIT ALLEGEDLY WAS NOT COMPATIBLE WITH THE BIOPSY NEEDLE. IT WAS FURTHER REPORTED THAT THE INTERNAL DIAMETER OF THE COAXIAL CANNULA ALLEGEDLY MAY BE SMALLER OR LARGER THAN THE EXTERNAL DIAMETER OF THE BIOPSY NEEDLE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18333630 ↗MalfunctionDec 15, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE COAXIAL NEEDLE IN THE KIT ALLEGEDLY WAS NOT COMPATIBLE WITH THE BIOPSY NEEDLE. IT WAS FURTHER REPORTED THAT THE INTERNAL DIAMETER OF THE COAXIAL CANNULA ALLEGEDLY MAY BE SMALLER OR LARGER THAN THE EXTERNAL DIAMETER OF THE BIOPSY NEEDLE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18333628 ↗MalfunctionOct 10, 2018Break; Break
IT WAS REPORTED THAT DURING A BIOPSY, THE STYLET NEEDLE ALLEGEDLY FRACTURED INSIDE THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7953924 ↗MalfunctionOct 10, 2018Break; Break
IT WAS REPORTED THAT DURING A BIOPSY, THE STYLET NEEDLE ALLEGEDLY FRACTURED INSIDE THE PATIENT. IT WAS FURTHER REPORTED THAT THE FRACTURED NEEDLE REMAINED INSIDE THE PATIENT AS THE HEALTHCARE PROFESSIONAL WAS UNABLE TO RETRIEVE IT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7953583 ↗
Other INSTRUMENT, BIOPSY devices
- MAX-CORE MC1616Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall4,258 reports
- ENCOR® ECP017GSenorx, Inc. · INSTRUMENT, BIOPSY1 recall4,186 reports
- MAX-CORE MC1820Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall2,404 reports
- MAX-CORE MC1816Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall1 death848 reports
- MAX-CORE MC1410Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall399 reports
- MAX-CORE MC1610Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall394 reports
- ENCOR® ECP0110GVSenorx, Inc. · INSTRUMENT, BIOPSY392 reports
- ENCOR® ECP0110GSenorx, Inc. · INSTRUMENT, BIOPSY390 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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